This example has been updated according to the approached discussed on the team call on 1/17. Additionally, we have simplified the Tobacco Product Identifiers and Descriptors (TO) domain by using parameters (TOPARM) instead of tests (TOTEST)
This is an example for the required tobacco product characterization, property description, and design parameter information in an FDA marketing application for one type of tobacco product Electronic Nicotine Delivery System (ENDS) (Vapes). There are many more and various types of tobacco products, and their parameters can be found in the in the FDA final rule and guidance documents for tobacco product Premarket Authorization (PMTA) and Substantial Equivalence pathways. The applicant submitting for SE and PMTAs may include test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results as applicable for these parameters.
Tobacco Product Identifier (TO) (similar to Device Identifiers (DI)) is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. The primary purpose of this dataset is to provide a list of the products used in an application or study and to provide identifying information for each product, such as product category type, manufacturer, properties, product name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Product Identifier (SPTOBID), a consistent variable, that is available for use in other domains where data pertaining to the product may be found.
Rows 1-4:
Show the records for a tobacco product given SPTOBID of VAPE-Z27.
Rows 1-3:
Show the tobacco product is a Electronic Nicotine Delivery Systems (ENDS) Vape closed e-cigarette.
Rows 5-8:
Show the package type is a Box that contains 1 E-Cigarette that is 107.2 mm long and 9.0 mm in diameter.
Rows 9-12:
Show the attributes or characteristics of the content of the e-liquid within the E-cigarette.
Rows 13-15:
Show the attributes or characteristics of the heating element for the E-cigarette .
to.xpt
to.xpt
Row
STUDYID
DOMAIN
SPTOBID
TOSEQ
TOPARMCD
TOPARM
TOCAT
TOVAL
TOVALU
1
TOB09
TO
VAPE-Z27
1
TBPRDCAT
Tobacco Product Category
PRODUCT IDENTIFIER
ENDS (VAPES)
2
TOB09
TO
VAPE-Z27
2
TBPRSCAT
Tobacco Product Subcategory
PRODUCT IDENTIFIER
Closed E-Cigarette
3
TOB09
TO
VAPE-Z27
3
MANUF
Manufacturer
PRODUCT IDENTIFIER
Joes Vapes USA
4
TOB09
TO
VAPE-Z27
4
TRADENAM
Trade Name
PRODUCT IDENTIFIER
Everyday Rich Tobacco
5
TOB09
TO
VAPE-Z27
5
PACKTYP
Package Type
PRODUCT DESCRIPTOR
BOX
6
TOB09
TO
VAPE-Z27
6
PRDQUAN
Product Quantity
PRODUCT DESCRIPTOR
1
E-CIGARETTE
7
TOB09
TO
VAPE-Z27
7
LENGTH
Length
PRODUCT DESCRIPTOR
107.2
mm
8
TOB09
TO
VAPE-Z27
8
DIAMETER
Diameter
PRODUCT DESCRIPTOR
9
mm
9
TOB09
TO
VAPE-Z27
9
NICTNCNC
Nicotine Concentration
PRODUCT DESCRIPTOR
2
mg/L
10
TOB09
TO
VAPE-Z27
10
PGVGRT
PG/VG Ratio*
PRODUCT DESCRIPTOR
50/50
11
TOB09
TO
VAPE-Z27
11
CHTRFLAV
Characterizing Flavor
PRODUCT DESCRIPTOR
TOBACCO
12
TOB09
TO
VAPE-Z27
12
VOLUMEE
Volume, E-liquid
PRODUCT DESCRIPTOR
1
mL
13
TOB09
TO
VAPE-Z27
13
WATT
Wattage
PRODUCT DESCRIPTOR
5.2
Watt
14
TOB09
TO
VAPE-Z27
14
BATTCAP
Battery Capacity
PRODUCT DESCRIPTOR
600
mAh
15
TOB09
TO
VAPE-Z27
15
DISPCRTG
Disposable Cartridge
PRODUCT DESCRIPTOR
Y
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Please add a row column to your dataset.
The Product Design Parameters (PD) domain is used to represent design specification parameters of the tobacco product. Each property is identified using controlled terminology and is stored in PDPARMCD/PDPARM.
Rows 1-94:
Show the design parameter specification with target, minimum, and maximum value reflected in the PDCOLSRT variable.
Rows 80-82:
Show the design parameter specification with the test condition of 20 degrees Celsius using the PDTSTCND variable.
*PG/VG Ratio = Propylene Glycol to Vegetable Glycerin Ratio
The Tobacco Product Testing (PT) (similar to the Laboratory Test Results (LB) domain) dataset shows the tobacco product test demonstrating the actual tests and test results for the specified Design Parameter Specification as noted in the DU dataset (??? PD dataset).
Rows 1-32:
Show the tobacco design parameter specification test and the result in ORRES (needs populated).
Row 28:
Shows the design parameter specification test condition of 20 degrees Celsius using the TTTSTCND variable for the E-Liquid Viscosity test.
